ONE-CARE OPTI TB Safety Syringes 1ml x 28G x 0.5’’ (12.7mm) 2143

GUDID 00810008214527

ONE-CARE OPTI Tuberculin Safety Syringes with fixed needle are sterile, single use devices intended for injection of fluids into the body. Designed to aid in prevention of needle stick injuries. They provide users with audible indication when the shield is pushed forward and then turned right or left to permanently lock the needle (''Click''). Large barrel flanges allow for secured grip and control of dosing.

MediVena, LLC

Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle Metered-delivery hypodermic syringe/needle
Primary Device ID00810008214527
NIH Device Record Keyb92d1c81-d543-4e58-ae90-5954ba33d0e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameONE-CARE OPTI TB Safety Syringes 1ml x 28G x 0.5’’ (12.7mm)
Version Model NumberONE-CARE OPTI TB Safety Syringes 1ml x 28G x 0.5'’
Catalog Number2143
Company DUNS080740980
Company NameMediVena, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com
Phone4045142586
Emailinfo@medivena.com

Device Dimensions

Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch
Total Volume1 Milliliter
Needle Gauge28 Gauge
Length0.5 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100810008214510 [Primary]
GS100810008214527 [Package]
Contains: 00810008214510
Package: Box [100 Units]
In Commercial Distribution
GS100810008214534 [Package]
Package: case [8 Units]
In Commercial Distribution

FDA Product Code

MEGSyringe, Antistick

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-05
Device Publish Date2024-02-26

Devices Manufactured by MediVena, LLC

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00810008211021 - ONE-CARE PRO Safety Lancets2024-03-05 MediVena ONE-CARE PRO Push Button Activated Safety Lancets are disposable, single-use, preloaded devices with needlestick preven
00810008211038 - ONE-CARE PRO Safety Lancets, Button-Activated, 25G x 1.6mm2024-03-05 MediVena ONE-CARE PRO Push Button Activated Safety Lancets are disposable, single-use, preloaded devices with needlestick preven
00810008211045 - ONE-CARE PRO Safety Lancets, Button-Activated, 21G x 1.8mm2024-03-05 MediVena ONE-CARE PRO Push Button Activated Safety Lancets are disposable, single-use, preloaded devices with needlestick preven
00810008211120 - ONE-CARE PRO Safety Lancets, Button-Activated, 21G x 2.4mm2024-03-05 MediVena ONE-CARE PRO Push Button Activated Safety Lancets are disposable, single-use, preloaded devices with needlestick preven
00810008214473 - GLUCO-CARE Safety Lancets 28G x 1.8mm2024-03-05 MediVena GLUCO-CARE Contact-Activated Safety Lancets are disposable, single-use, preloaded devices with needlestick prevention m
00810008214381 - GLUCO-CARE Safety Lancets 30G x 1.8 mm2024-03-05 MediVena GLUCO-CARE Contact-Activated Safety Lancets are disposable, single-use, preloaded devices with needlestick prevention m
00810008214480 - GLUCO-CARE Safety Lancets, Contact-Activated, 26Gx 1.8mm2024-03-05 MediVena GLUCO-CARE Contact-Activated Safety Lancets are disposable, single-use, preloaded devices with needlestick prevention m

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